How Chiesi Global Rare Diseases is positioning lomitapide for earlier lifecycle management in HoFH
CHMP backs paediatric lomitapide for HoFH. Read what this means for clinicians, regulators, and rare disease access across Europe.
Why Incyte’s povorcitinib 54-week results matter for hidradenitis suppurativa treatment
Incyte’s povorcitinib reaches 71.4% HiSCR50 at 54 weeks in HS. Analysis of what the STOP-HS data mean for the JAK1 class and the treatment landscape.
How Bristol Myers Squibb’s Opdivo approvals in frontline and relapsed classical Hodgkin lymphoma reset treatment pathways
Nivolumab wins U.S. frontline and EU relapsed cHL approvals. Analyse what the dual verdict means for sequencing, safety, and reimbursement.
Gazyva’s ALLEGORY data: what the SRI-4 and DORIS remission outcomes mean for lupus care
Genentech’s obinutuzumab met all ALLEGORY phase III endpoints in SLE. What the remission and flare data mean for lupus treatment strategy.
How Brazil’s GMP approval for pembrolizumab biosimilar changes global biosimilar dynamics
Blau Farmacêutica’s pembrolizumab biosimilar earns ANVISA GMP approval—see what this means for Brazil’s global position in cancer immunotherapy.
What AGC Biologics’ role in Waskyra tells us about the future of ethical cell therapy scale-up
Waskyra’s FDA and EMA approvals spotlight AGC Biologics’ rare disease manufacturing model. Find out what this means for future nonprofit-led therapies.
Can Novo Nordisk’s semaglutide 7.2 mg set a new standard in obesity treatment?
Novo Nordisk’s semaglutide 7.2 mg achieves 20.7% weight loss. Find out what this EU regulatory step means for obesity treatment and patient outcomes in 2026.
EMA backs ANKTIVA for bladder cancer: What it means for EU patients and future immunotherapies
ImmunityBio Inc. has received a positive recommendation from the European Medicines Agency for conditional marketing authorization of its immunotherapy ANKTIVA (nogapendekin alfa inbakicept) in combination with Bacillus Calmette-Guérin for the treatment of BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. The recommendation positions ANKTIVA as the first immunotherapy in the European Union for this indication, […]
Merck’s WINREVAIR clears major EU hurdle with CHMP backing for WHO FC IV patients
Merck has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an expanded indication for WINREVAIR (sotatercept) in combination with other therapies for the treatment of pulmonary arterial hypertension (PAH) in adults across WHO Functional Classes II, III, and IV. The update follows pivotal […]
Can Gotenfia finally unlock biosimilar competition for Simponi in Europe?
STADA Arzneimittel AG and Bio-Thera Solutions have secured a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Gotenfia, a proposed biosimilar to the tumor necrosis factor alpha inhibitor golimumab. The product references Simponi, an originator drug widely prescribed for multiple autoimmune conditions. If approved, Gotenfia would be marketed […]